MIRTAZAPINA 30 mg Tabletki Orodispersyjne

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1. Mirtazapina Aurobindo 30 mg orodispersible tablets
   1. What is Mirtazapina Aurobindo and what is it used for
   2. What you need to know before taking Mirtazapina Aurobindo
   3. How to take Mirtazapina Aurobindo
   4. Do not break the orally disintegrating tablet
   5. Detach a tablet indentation
   6. Lift the cover sheet
   7. Remove the orodispersible tablet
   8. Possible side effects
   9. How to store Mirtazapina Aurobindo
   10. Contents of the pack and other information

Mirtazapina Aurobindo 30 mg orodispersible tablets

Generic medicine

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Mirtazapina Aurobindo is and what it is used for
• 2. What you need to know before you take Mirtazapina Aurobindo
• 3. How to take Mirtazapina Aurobindo
• 4. Possible side effects
• 5. How to store Mirtazapina Aurobindo
• 6. Contents of the pack and other information

1. What is Mirtazapina Aurobindo and what is it used for

Mirtazapina Aurobindo belongs to a group of medicines called antidepressants.
Mirtazapina Aurobindo is used to treat depressive disorders in adults.
It takes 1-2 weeks before Mirtazapina Aurobindo starts to work. After 2-4 weeks you may
begin to feel better. Contact your doctor if you do not feel better or if you feel worse after 2-4 weeks.
More information is contained in paragraph 3, entitled “When can you expect to feel
better”.

2. What you need to know before taking Mirtazapina Aurobindo

Do not take Mirtazapina Aurobindo

• if you are allergicto mirtazapine or any of the other ingredients of this medicine (listed in section 6). In this case, you should tell your doctor as soon as possible before taking Mirtazapina Aurobindo.
• if you are taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAO-Is).

Warnings and precautions
Talk to your doctor or pharmacist before taking Mirtazapina Aurobindo.

DO NOT TAKE - OR - TELL YOUR DOCTOR BEFORE TAKING MIRTAZAPINA
AUROBINDO:
if you have had a severe rash or skin peeling, blisters and/or mouth ulcers
after taking mirtazapine or other medicines.

Children and adolescents
Mirtazapina Aurobindo is generally not recommended for use in children and adolescents under the age of 18
because its efficacy has not been demonstrated. It should be known that in patients under the age of 18
this class of drugs is associated with an increased risk of adverse effects, such as suicide attempts,
suicidal thoughts and hostility (particularly aggression, argumentative behavior and anger). Nevertheless, the
doctor may prescribe Mirtazapina Aurobindo to patients under the age of 18 if they believe that this is in
their best interest. If the doctor has prescribed Mirtazapina Aurobindo to a patient under the age of 18 and you
wish to discuss this, talk to your doctor. You should tell your doctor if any of the symptoms described
above develop or worsen when a patient under the age of 18 is taking Mirtazapina Aurobindo.
It should also be noted that the long-term safety effects of Mirtazapina Aurobindo in this
age group in terms of growth, maturation and cognitive and behavioral development have not yet been
demonstrated. In addition, a significant increase in weight has been observed in this age group if treated
with Mirtazapina Aurobindo, more frequently than in adults.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes think about harming yourself or committing suicide. These thoughts may increase
immediately after starting treatment with antidepressants, as these medicines take time to work,
usually about two weeks but sometimes longer.
You are more likely to have thoughts of this kind if:

• you have thought about committing suicide or harming yourself in the past.
• if you are a young adult. Information from clinical studies has shown an increased risk of suicidal behavior in adults under the age of 25 with mental illnesses treated with antidepressants. → If at any time you find yourself thinking about committing suicide or harming yourself, contact your doctor or go to hospital immediately. It may be helpful to confide in a relative or friendthat you are depressed and ask them to read this leaflet. You can ask them to let you know if they think your depression is getting worse, or if they are worried about changes in your behavior.

Pay particular attention with Mirtazapina Aurobindo also

• if you suffer or have suffered in the past from any of the conditions listed below. → If you have not already done so, tell your doctor about these conditions before taking Mirtazapina Aurobindo:
• seizures(epilepsy). If you start having seizures or if seizures become more frequent, stop taking Mirtazapina Aurobindo and contact your doctor immediately;
• liver diseases, including jaundice. If you develop jaundice, stop taking Mirtazapina Aurobindo and contact your doctor immediately.
• kidney diseases;
• heart diseaseor low blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or severe, contact your doctor immediately.
• manic depression(periods of euphoria/hyperactivity and depressed mood). If you start to feel euphoric or overexcited, stop taking Mirtazapina Aurobindo and contact your doctor immediately.
• diabetes(it may be necessary to adjust the dose of insulin or other anti-diabetic drugs).
• eye diseases, such as increased pressure in the eye (glaucoma).
• difficulty urinating, which may be caused by an enlarged prostate.
• some types of heart diseasethat can change your heart rhythm, a recent heart attack, heart failure or taking certain medicines that can affect your heart rhythm.
• if you develop signs of infection, such as unexplained high fever, sore throat and mouth ulcers. → Stop taking Mirtazapina Aurobindoand contact your doctor immediately for a blood test. In rare cases, these symptoms may be signs of a blood cell production disorder in the bone marrow. Although rare, these symptoms are more common after 4-6 weeks of treatment.
• if you are elderly. You may be more sensitive to the side effects of antidepressants.
• with the use of Mirtazapina Aurobindo, serious skin reactions have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using it and seek immediate medical attention if you notice any of the symptoms described in section 4 in relation to these serious skin reactions. If you have had serious skin reactions in the past, treatment with mirtazapine should not be restarted.

Other medicines and Mirtazapina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Do not take Mirtazapina Aurobindoin combination with:

• monoamine oxidase inhibitors(MAO inhibitors). Also, do not take Mirtazapina Aurobindo within two weeks of stopping MAO inhibitors. Similarly, if you stop taking Mirtazapina Aurobindo, do not take MAO inhibitors within two weeks of stopping it. MAO inhibitors include, for example, moclobemide, tranylcypromine (both are antidepressants) and selegiline (used in Parkinson's disease).

Be careful whentaking Mirtazapina Aurobindo in combination with:

• antidepressants such as SSRIs, venlafaxine and L-tryptophan or triptans(used to treat migraine), tramadol(for pain relief), linezolid(an antibiotic), lithium(used to treat certain mental conditions), methylene blue(used to treat high levels of methemoglobin in the blood) and St. John's wort preparations(a herbal remedy for depression). Very rarely, Mirtazapina Aurobindo, alone or in combination with these medicines, can lead to the so-called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, increased heart rate, diarrhea, muscle contractions (uncontrollable), tremor, hyperactive reflexes, restlessness, mood changes and loss of consciousness. If you experience a combination of these symptoms, tell your doctor immediately.
• the antidepressant called nefazodone, which can increase the amount of Mirtazapina Aurobindo in the blood. Tell your doctor if you are using this medicine as this may require a reduction in the dose of Mirtazapina Aurobindo or, when the use of nefazodone is stopped, an increase in the dose of Mirtazapina Aurobindo.
• medicines for anxiety or insomnia, such as benzodiazepines; medicines for schizophrenia, such as olanzapine; medicines for allergies, such as cetirizine; medicines for severe pain, such as morphine. If taken in combination with these medicines, Mirtazapina Aurobindo may increase the drowsiness caused by these substances.
• medicines for treating infections;medicines for bacterial infections (such as erythromycin), medicines for treating fungal infections (such as ketoconazole) and medicines for treating HIV/AIDS (such as HIV protease inhibitors) and medicines for stomach ulcers(such as cimetidine). These medicines, in combination with Mirtazapina Aurobindo, can increase the amount of Mirtazapina Aurobindo in the blood. Tell your doctor if you are using these medicines. It may be necessary to reduce the dose of Mirtazapina Aurobindo or, when the use of these medicines is stopped, increase the dose of Mirtazapina Aurobindo again.
• medicines for epilepsy, such as carbamazepine and phenytoin;
• medicines for tuberculosis, such as rifampicin. These medicines, in combination with Mirtazapina Aurobindo, can decrease the amount of Mirtazapina Aurobindo in the blood. Tell your doctor if you are using these medicines. It may be necessary to increase the dose of Mirtazapina Aurobindo or, when the use of these medicines is stopped, lower the dose of Mirtazapina Aurobindo again.
• medicines that prevent blood clotting, such as warfarin. Mirtazapina Aurobindo may increase the effects of warfarin in the blood. Tell your doctor if you are using this medicine. In case of concomitant use of warfarin, the doctor must keep the blood under strict control.
• medicines that can affect heart rhythm, such as certain antibiotics and some antipsychotics.

Mirtazapina Aurobindo with food, drinks and alcohol
You may feel sleepy if you drink alcohol while taking Mirtazapina Aurobindo.
It is best not to drink alcohol.
Mirtazapina Aurobindo can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Limited experience with the administration of Mirtazapina Aurobindo to pregnant women does not
indicate an increased risk. However, caution should be exercised when administering Mirtazapina Aurobindo
during pregnancy.
If used during pregnancy, the newborn must be carefully monitored for possible adverse effects.
Make sure your midwife and/or doctor know that you are taking Mirtazapina Aurobindo. If taken
during pregnancy, similar drugs (SSRIs) can increase the risk of a serious condition in
babies, called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually start within the first 24 hours after the birth of
the baby. If this happens to your baby, you should contact your midwife and/or doctor
immediately.

Driving and using machines
Mirtazapina Aurobindo can affect concentration or alertness. Make sure your abilities are not
impaired before driving or using machines. If the doctor has prescribed Mirtazapina Aurobindo to
a patient under the age of 18, make sure their concentration and responsiveness are not
affected before entering traffic (e.g. cycling).

Mirtazapina Aurobindo orodispersible tablets contains aspartame.
Mirtazapina Aurobindo orodispersible tablets contains aspartame, a source of phenylalanine. It may
be harmful for people with phenylketonuria.

3. How to take Mirtazapina Aurobindo

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

How much Mirtazapina Aurobindo to take
The recommended initial dose is 15 or 30 mg per day.Your doctor may advise you to increase the dose
after a few days to reach the appropriate amount (between 15 and 45 mg per day). Normally the dose is
the same for all ages. However, your doctor may adjust the dose if you are elderly or if you have had a disease
of the kidneys or liver.

When to take Mirtazapina Aurobindo
→ Take Mirtazapina Aurobindo every day at the same time.
It is best to take Mirtazapina Aurobindo as a single dose before going to bed. In any case, your doctor
may suggest dividing the dose of Mirtazapina Aurobindo, once in the morning and once in the evening before
going to bed. The highest dose should be taken before bedtime.

Take the orally disintegrating tablet as indicated below:
Take the tablets orally.

1. Do not break the orally disintegrating tablet

To prevent breakage of the orally disintegrating tablet, do not press on the tablet’s indentation on the
blister pack (figure A).

Fig. A.

2. Detach a tablet indentation

Each blister pack contains 6 tablets (indentations), which are separated by perforated lines. Detach one
portion by tearing along the perforated lines (figure 1).

Fig. 1.

3. Lift the cover sheet

Carefully lift the cover sheet, starting from the corner indicated by the arrow (figures 2 and 3).

Fig. 2.

Fig. 3.

4. Remove the orodispersible tablet

The orodispersible tablet must be removed from its housing with dry hands and placed on the tongue.
(Figure 4).

Fig. 4.
It will disintegrate rapidly and can be swallowed without water.

When you can expect to feel better
Normally Mirtazapina Aurobindo takes 1-2 weeks to start working and after 2-4 weeks you may
notice an improvement.
It is important that in the first few weeks of treatment you inform your doctor about the effects of Mirtazapina
Aurobindo:
→ 2-4 weeks after starting to take Mirtazapina Aurobindo, discuss with your doctor the effects that the
medicine has had on you.
If you continue to notice no improvement, your doctor may prescribe you a higher dose. In this
case, talk to your doctor again after another 2-4 weeks. Normally you need to take
Mirtazapina Aurobindo for 4-6 months after the disappearance of the symptoms of depression.

If you take more Mirtazapina Aurobindo than you should
→ If you or someone else takes too much Mirtazapina Aurobindo, call your doctor immediately.
The most common signs of an overdose of Mirtazapina Aurobindo (without other medicines or alcohol) are

drowsiness, disorientation and increased heart rate. Symptoms of a possible overdose
may include changes to your heart rhythm (fast, irregular heartbeat) and/or fainting which
may be symptoms of a life-threatening condition known as torsades de pointes.

If you forget to take Mirtazapina Aurobindo
If you have to take the dose once a day

• Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

If you have to take the dose twice a day

• if you forget the morning dose, simply take this dose together with the evening dose.
• if you forget the evening dose, you should not take it together with the morning dose afterwards; skip the dose and continue normally with the morning and evening dose.
• if you have forgotten to take both doses, you should not try to make up for the missed dose. Skip both doses and continue the next day normally with the morning and evening dose.

If you stop taking Mirtazapina Aurobindo
→ You can only stop taking Mirtazapina Aurobindo after consulting your doctor.
If you stop taking it too soon, the depression may return. When you feel better, talk to your
doctor about it. Your doctor will decide when to stop treatment.
Do not suddenly stop taking Mirtazapina Aurobindo, even if the depression has
disappeared. If you suddenly stop Mirtazapina Aurobindo you may feel unwell, dizzy, agitated or anxious and have a headache. These symptoms can be avoided by stopping the
treatment gradually. Your doctor will tell you how to reduce the dose gradually.
If you have any further questions, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking
Mirtazapina Aurobindo and seek immediate medical attention.
Not common(may affect up to 1 in 100 people):

• euphoria or emotional excitement (mania)

Rare(may affect up to 1 in 1,000):

• yellowing of the eyes and skin; this may indicate problems with liver function (jaundice). Not known(frequency cannot be estimated from the available data):
• signs of infection such as sudden, unexplained high fever, sore throat and stomatitis (agranulocytosis). In rare cases Mirtazapina Aurobindo may cause a disorder of blood cell production (bone marrow depression). Some people become less resistant to infections because Mirtazapina Aurobindo can cause a temporary deficiency of white blood cells (granulocytopenia). In rare cases Mirtazapina Aurobindo can also cause a deficiency of white and red blood cells, and platelets (aplastic anemia), a deficiency of platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia).
• seizures (convulsions)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhea, muscle contractions (involuntary), tremor, hyperactive reflexes, fatigue, mood changes, loss of consciousness and increased salivation. Very rarely these may be symptoms of serotonin syndrome.
• thinking about harming yourself or taking your own life
• Reddish patches on the trunk or target- or circular-shaped macules, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug reaction with eosinophilia and systemic symptoms).

Other possible side effects of Mirtazapina Aurobindo are:
Very common(may affect more than 1 in 10 people) :

• increased appetite and body weight
• drowsiness
• headache
• dry mouth

Common(may affect up to 1 in 10 people) :

• lethargy
• dizziness
• tremor
• nausea
• diarrhea
• vomiting
• constipation
• rash or skin eruptions (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• feeling lightheaded or fainting when getting up suddenly (orthostatic hypotension)
• swelling (usually in the ankles and feet) caused by fluid retention (edema)
• fatigue
• vivid dreams
• confusion
• anxiety
• sleep problems
• memory problems, which in most cases resolved with discontinuation of treatment

Not common(may affect up to 1 in 100 people) :

• abnormal skin sensations, e.g. burning, tingling, itching or pins and needles (paresthesia)
• restless legs syndrome
• fainting (syncope)
• feeling of numbness in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• need to move

Rare(may affect up to 1 in 1,000) :

• muscle contraction (myoclonus)
• aggression
• abdominal pain and nausea; this may indicate inflammation of the pancreas (pancreatitis)

Not known (frequency cannot be estimated from the available data):

• abnormal sensation in the mouth (oral paresthesia)
• swelling of the mouth (oral edema),
• swelling all over the body (generalized edema)
• localized swelling
• hyponatremia
• inappropriate secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking
• speech disorders
• increased blood levels of creatine kinase
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, dark or discolored urine (rhabdomyolysis)
• increased levels of the hormone prolactin in the blood (hyperprolactinemia, including symptoms of breast enlargement and/or milky nipple discharge)

Additional side effects in children and adolescents
In children under 18 years of age, the following adverse effects have been commonly observed in clinical studies: significant weight gain, urticaria and increased triglycerides in the blood.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mirtazapina Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mirtazapina Aurobindo contains

• The active ingredient is mirtazapine. Each orally disintegrating tablet contains 30 mg of mirtazapine.
• The other ingredients are: crospovidone (type B), mannitol (E421), microcrystalline cellulose, aspartame (E951), anhydrous colloidal silica, magnesium stearate, strawberry and guarana flavour [maltodextrin, propylene glycol, artificial flavours, acetic acid] and peppermint flavour [artificial flavours, corn starch].

Description of the appearance of Mirtazapina Aurobindo and contents of the pack
Orally disintegrating tablet.
White orally disintegrating tablets, spherical in shape (diameter 8.0 mm), with a raised circular edge, and with
the number “37” embossed on one side and the letter ‘A’ on the opposite side.
Mirtazapina Aurobindo orally disintegrating tablets are available in perforated blister packs made of
polyamide/aluminium/PVC/paper/polyester/aluminium containing 30 tablets.

Marketing Authorisation Holder:
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturers:
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road, South Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, no 19,
2700-487 Amadora,
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Mirtazapina Aurobindo 30 mg orally disintegrating tablets